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The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

NCT05234554 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2026-05-14

Study results available
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Summary

The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (EEC).

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) dosed twice.

DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution dosed twice.

Sponsors & Collaborators

  • Aldeyra Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2023-04-22
Completion
2023-04-22
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234554 on ClinicalTrials.gov